Medical device manufacturer, RaySearch Laboratories AB (publ), has issued a medical device safety alert concerning the following:
The manufacturer described two issues. This first issue affects RayStation 8B, 9A, 9B, 10A and 10B on the Robust evaluation module of voxelwise worst clinical goals and the second one involves RayStation/RayPlan versions from 6 up to 10A with contouring when CT slice spacing is ≤ 1 mm.
According to the manufacturer's Health Hazard Evaluation, if a clinical decision is based on the incorrect display, this could lead to the approval of an inappropriate dose plan. This could lead to local over-dose in a risk organ or local under-dose to the target.
The manufacturer advises users to take note of the error and its workaround when using the affected device and refer to the information contained in its notice for details.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 May 2021